Purpose

Major pathological response (MPR) rate of canakinumab given as a neoadjuvant treatment, either as single agent or in combination with pembrolizumab, in addition to evaluate the MPR rate of pembrolizumab as a single agent. Additionally the dynamics of the tumor microenvironment changes on treatment by comparing pre-, on- and post-treatment samples will be evaluated.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Histologically confirmed NSCLC stage IB-IIIA (per AJCC 8th edition), deemed suitable for primary resection by treating surgeon, except for N2 and T4 tumors. - Subject must be eligible for surgery and with a planned surgical resection in approximately 4-6 weeks (after the first dose of study treatment). - A mandatory newly obtained tissue biopsy from primary site is required for study enrollment. An archival biopsy is also acceptable if obtained up to 5 months before first day of study treatment and if the subject did not go through antineoplastic systemic therapies between biopsy collection date and beginning of study treatment. Note: Aspirates will not be accepted. - Eastern Cooperative oncology group (ECOG) performance status of 0 or 1.

Exclusion Criteria

  • Subjects with unresectable or metastatic disease. - History of severe hypersensitivity reactions to monoclonal antibodies, which in the opinion of the investigator may pose an increased risk of serious infusion reaction - Subjects who received prior systemic therapy (including chemotherapy, other anti-cancer therapies and any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways) in the past 3 years before screening - Active autoimmune disease that has required systemic treatment in the past 2 years prior to randomization. Control of the disorder with replacement therapy is permitted - Subject with suspected or proven immunocompromised state or infections Other protocol-defined inclusion/exclusion criteria may apply.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
canakinumab monotherapy
All patients will receive canakinumab (ACZ885) prior to surgery
  • Drug: canakinumab
    Administered subcutaneously
    Other names:
    • ACZ885
Experimental
canakinumab + pembrolizumab
All patients will receive canakinumab (ACZ885) and pembrolizumab prior to surgery
  • Drug: canakinumab
    Administered subcutaneously
    Other names:
    • ACZ885
  • Drug: pembrolizumab
    200mg administered intravenously every 3 weeks
Experimental
pembrolizumab monotherapy
All patients will receive 2 doses of pembrolizumab prior to surgery
  • Drug: pembrolizumab
    200mg administered intravenously every 3 weeks

Recruiting Locations

University of Kansas Medical Center Neurology Dept.
Kansas City, Kansas 66160
Contact:
Darlene Kocher
913-588-3968
dkocher@kumc.edu

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.